Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

OMP 2020-05-18

V.A.C. DERMATAC Drape

Applicant Kci USA, Inc.

K-Number K200390

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FMF 2020-05-18

3D GraftRasp System

Applicant Surgentec

K-Number K200431

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EBG 2020-05-18

VarseoSmile Temp

Applicant Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG

K-Number K193553

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NHA 2020-05-18

UF(II) Bar holder abutment

Applicant Dio Corporation

K-Number K193404

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LLZ 2020-05-18

syngo Ultrasound Apps Suite (sUSAS)

Applicant Siemens Medical Solutions USA, Inc.

K-Number K201062

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OMB 2020-05-18

Natus NeuroWorks

Applicant Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

K-Number K200878

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MAX 2020-05-18

MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF

Applicant MiRus, LLC

K-Number K191906

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QEP 2020-05-17

Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)

Applicant Hologic, Inc.

K-Number K200866

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MUE 2020-05-15

Pristina Serena Bright

Applicant GE Healthcare

K-Number K193334

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LPN 2020-05-15

PuriLens Plus Preservative Free Saline

Applicant The Lifestyle Company, Inc.

K-Number K200747

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DXN 2020-05-15

Medtronic Commander Flex

Applicant Medtronic Care Management Services

K-Number K191745

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HSD 2020-05-15

Biocore9 Humeral Resurfacing System

Applicant Biocore9, LLC

K-Number K193122

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